MAUDE Adverse Event Report: ACUMED LLC 20.0MM HEAD, LEFT; PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD

Model Number TR-H200L-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

A visual examination of the returned radial head was performed under magnification.The radial head has a clean, smooth surface inside and out, without any wear or discoloration.Additional mdr associated with this event: 3025141-2020-00196; stem.

Event Description

An arh radial head replacement system was implanted in the patient two years ago.Post op, the patient developed an allergic reaction that moved throughout the body so the hardware was removed.

• Brand Name: 20.0MM HEAD, LEFT
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro, or
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, or ; 6279957138
• MDR Report Key: 10425668
• MDR Text Key: 203502911
• Report Number: 3025141-2020-00195
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TR-H200L-S
• Device Catalogue Number: TR-H200L-S
• Device Lot Number: 421449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention